Dynepo Infrequent Dosing Study

NCT00450333 | Terminated Phase 3 Results

• 2 other identifiers: SPD490-3012006-002052-15
• Study Type: interventional
• Target: 407
• Locations: 7 countries
• Sites: 53

Brief Summary

The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

Conditions

Anemia; Kidney Failure

Keywords

Chronic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks

  This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.

  Baseline and 24 weeks

Secondary Outcomes (2)

• Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL

  week 16 and 24

• Change From Baseline in Hematocrits at 16 and 24 Weeks

  Baseline and Weeks 16 and 24

Study Arms (4)

1

ACTIVE COMPARATOR

Erythropoietin(EPO)-naive BIW

Drug: Dynepo (Epoetin delta)

2

ACTIVE COMPARATOR

EPO-naive QW

Drug: Dynepo

3

ACTIVE COMPARATOR

EPO QW

Drug: Dynepo

4

ACTIVE COMPARATOR

EPO Q2W

Drug: Dynepo

Interventions

Dynepo (Epoetin delta) DRUG

subcutaneous, BIW for 24 weeks

1

Dynepo DRUG

subcutaneous, QW for 24 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative \[KDOQI\] stage III-V).
• Stable on and taking doses \<= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
• Transferrin saturation \>= 20% and ferritin \>= 100 ng/mL.

You may not qualify if:

• Uncontrolled hypertension.
• Requiring doses of EPO \> 10,000 IU/week.
• Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
• Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
• Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
• Androgen therapy in the 30 days immediately prior to randomisation in the study.
• Known Human Immunodeficiency Virus(HIV)infection.
• History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.

Sponsors & Collaborators

• Shire: lead

Study Sites (53)

Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse

Graz, Steiemark, A-8036, Austria

Location

Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie

Innsbruck, A-6020, Austria

Location

Hopital UCL, Service de Nephrologie

Brussels, B-1200, Belgium

Location

UZ Gasthuisberg, Leuve, Dept of Nephrology

Leuven, B-3000, Belgium

Location

Hellig Hart Ziekenhuis, Campus Wilgenstraat

Roeselare, B-8800, Belgium

Location

CHU - Hopital Pellegrin, Nephrologie-Hemodialyse

Bordeaux, 33076, France

Location

CH de Boulogne-sur-mer (Hopital de Dr Duchenne)

Boulogne-sur-Mer, 62321, France

Location

Hopital Clemenceau, Nephrologie-Hemodialyse

Caen, 14033, France

Location

CHU (Centre Hospitalier Universitaire)

Grenoble, 38043, France

Location

CHU Hotel Dieu, Service du Pr Soulillou

Nantes, 44093, France

Location

Clinique de Landy, Service de Nephrologie - Hemodialyse

Saint-Ouen, 93400, France

Location

Hopital Sud, Service du Pr Fournier

Salouël, 80480, France

Location

CHU Hopital Civil, Nephrologie-Hemodialyse

Strasbourg, 67091, France

Location

Hopital Rangueil, Service du Pr Durand

Toulouse, 31403, France

Location

Hopital Brabois Adultes, Nephrologie

Vandœuvre-lès-Nancy, 54511, France

Location

Nephrologische Zentrum Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany

Location

KfH Nierenzentrum Bamberg

Bamberg, Bavaria, 96050, Germany

Location

KfH Nierenzebtrum im Linikum Rosenheim

Rosenheim, Bavern, 83022, Germany

Location

Dialyse-und Apheresezentrum Potsdam-Bebelsberg

Potsdam, Brandenburg, 14482, Germany

Location

KfH Nierenzentrum Fulda

Fulda, Hesse, 36043, Germany

Location

KfH Nierenzentrum am Handr-Klinikum Stralsund

Stralsund, Mecklenburg-Vorpommern, 18435, Germany

Location

Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Praxis Dr. Vosskuhler

Bottrop, North Rhine-Westphalia, 46242, Germany

Location

Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe

Düsseldorf, North Rhine-Westphalia, 40210, Germany

Location

KfK Nierenzentrum Nurnberg

Nuremberg, 90471, Germany

Location

Ospedali Riuniti

Foggia, Apulia, 71100, Italy

Location

Universita' degli Studi di Napoli Federico II

Napoli, Campania, 80131, Italy

Location

Policlinico S. Orsola Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

Azienda Ospedaliera Universitaria Policlinico di Modena

Modena, Emillia Romagna, 41100, Italy

Location

Azienda Ospedaliera S.Giovanni-Addolorata

Rome, Lazio, 00184, Italy

Location

Spedali Civil Brescia

Brescia, Lombardy, 25123, Italy

Location

Ospedale Nuovo Alessandro Manzoni

Lecco, Lombardy, 23900, Italy

Location

Azienda Ospedaliera CTO/CRF/M.Adelaide

Turin, Piedmont, 10126, Italy

Location

A.R.N.A.S Civico Palermo

Palermo, Sicily, 90127, Italy

Location

Azienda Sanitaria Locale 4 Area Pratese

Prato, Tuscany, 59100, Italy

Location

Hospital Puerto Real

Puerto Real, Cadiz, 11510, Spain

Location

Hotel General Universitario

Castellon, Castellon, 120004, Spain

Location

Head of Nephrology, Fundacion Puigvert

Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Central de Asturias

Oviedo, 33006, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Doctor Peset

Valencia, 46017, Spain

Location

Hope Hospital

Salford, Manchester, M6 8HD, United Kingdom

Location

Richard Bright Renal Unit Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

Glasgow Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Kings College Hospital Renal Unit

London, SE5 9RS, United Kingdom

Location

Morrison Hospital

Swansea, SA6 6NL, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (2)

• Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

  PMID: 36791280 DERIVED

• Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35. doi: 10.1186/1745-6215-8-35.

  PMID: 17999759 DERIVED

MeSH Terms

Conditions

Anemia; Renal Insufficiency; Bronchiolitis Obliterans Syndrome

Interventions

Erythropoietin; epoetin delta

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 22, 2007
• Study Start: October 30, 2006
• Primary Completion: July 31, 2008
• Study Completion: July 31, 2008
• Last Updated: June 14, 2021
• Results First Posted: November 10, 2009

Record last verified: 2021-06

Locations

IT (10); AU (2); FR (10); BE (3); DE (10); ES (10); GB (8)